[Hiring] Regulatory Affairs Specialist II @Johnson & Johnson Innovative Medicine

Role Description

Johnson & Johnson is recruiting for a Regulatory Affairs Specialist II, MedTech Neurovascular. The Regulatory Affairs Specialist II position offers the opportunity to have a significant impact on patient access to innovative neurovascular products around the world!

The role will primarily support regulatory activities to obtain and maintain medical device approvals/clearances in the US and European markets. This role will support preparation, submission, tracking, indexing, and archiving of official documents and files such as:

• Technical Documents
• Amendments/Supplements
• Annual Reports
• General Correspondence
• Promotional Materials
• Other EU or US regulatory submissions

The individual will work closely with other Global Regulatory Affairs partners and with functional partners in:

• Research and Development (R&D)
• Medical Affairs
• Quality
• Supply Chain
• Marketing
• Other functions

Qualifications

• Required: BS with 2+ years of experience, or PhD, MS degree
• Preferred: Training in US and/or EU medical device regulations

Requirements

• Strong written and verbal communication skills, especially for conveying technical, scientific, and medical information in multiple technology formats and to different audiences
• Some knowledge of US and European regulatory processes
• Experienced in working as a member of a team
• Ability to communicate in a constructive manner to encourage new, diverse ideas
• Capability to work in an environment of innovative thinking, informed risk taking, intellectual curiosity, and continual learning of regulatory developments
• Preferred: Practical experience in a medical device regulatory environment
• Preferred: Practical experience working within a medical device quality system
• Preferred: Practical experience preparing submissions for Class II and III medical devices in the US and EU
• Language requirement: Proficiency in speaking, reading, and writing in English

Benefits

• Medical, dental, vision, life insurance
• Short- and long-term disability
• Business accident insurance
• Group legal insurance
• Consolidated retirement plan (pension) and savings plan (401(k))
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year